Multiple Sclerosis
Conditions
Interventions
A. 120 mg DMF (1 tablet of 120 mg DMF) as FP187-GC.
B. 240 mg DMF (2 tablets of 120 mg DMF) as FP187-GC.
C. 480 mg DMF (4 tablets of 120 mg DMF) as FP187-GC.
T. 240 mg DMF (1 capsule of 240 mg DMF) as
Sponsors
Forward Pharma GmbH
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Eligible subjects must meet all of the following inclusion criteria at screening: 1. Is informed and given ample time and opportunity to think about participation and has given his/her informed consent in writing. 2. Is a healthy Caucasian male or female aged between 18 and 55 years (inclusive) at screening. 3. Is in good general health in the opinion of the Investigator, as determined by absence of evidence of any active or chronic disease following a detailed medical history, physical examination, vital signs (systolic and diastolic blood pressure, pulse rate, body temperature), 12-lead electrocardiogram (ECG), and clinical laboratory parameters (hematology, blood chemistry, and urinalysis). Minor deviations of laboratory values from the normal range may be accepted, if judged by the Investigator to have no clinical relevance. 4. Is a female with childbearing potential and is either surgically sterile (hysterectomy or tubal ligation) or uses a highly effective (failure rate
Exclusion criteria
Exclusion criteria: Eligible subjects must meet none of the following exclusion criteria at screening: 1. Has legal incapacity or inability to understand or comply with the requirements of the study. 2. Has clinically significant abnormalities in physical examination, vital signs, 12-lead ECG, or clinical laboratory parameters (especially for leukocytes and differential count, liver enzymes, and serum creatinine) according to the Investigator*s judgment. In the case of uncertain or questionable results, tests performed during screening may be repeated once before randomization to confirm eligibility or judged to be clinically irrelevant for healthy subjects. 3. Has leukopenia (leukocyte count 0.75 x 10*9/L) or lymphocytopenia (count 139 or 89 or 90 beats/min. 9. Has Hepatitis B surface antigen (HBsAg), anti-Hepatitis B core antibody (anti-HBcore), Hepatitis C antibody (HCV Ab), or human immunodeficiency virus antibody (HIV Ab) at screening. 10. Has any significant allergic reactions (urticarial, rash, or anaphylaxis) against any drug, or multiple drug allergies (non-active hay fever is acceptable). 11. Has a history of chronic alcohol (regular intake of more than three units per day) or drug abuse within the last six months prior to first administration or evidence of such abuse as indicated by the laboratory profile conducted during the screening examination. Alcohol consumption will be prohibited during study confinement and at least 24 hours before screening, before dosing, and before each scheduled visit. 12. Is demonstrating excess in xanthine consumption (more than eight cups of coffee or equivalent per day 13. Uses any medications (prescription or over-the-counter (OTC)) within 21 days of study drug administration, or less than five half-lives (whichever is longer). Exception is paracetamol (up to 4000 mg/day). Other exceptions will only be made if the rationale is discussed with the Principal Investigator and clearly documented. 14. Received any treatment agents known to alter the major organs or systems within one month prior to the first administration (e.g., barbiturates, phenothiazines, cimetidine, etc.). 15. Participated in an investigational drug or device study within three mo
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PK endpoints The plasma PK parameters for MMF in plasma will be derived by non-compartmental analysis of the plasma concentration-time profiles, as will the PK parameters for the amount of the DMF and MMF metabolites determined in plasma, whole blood, and urine. The PK parameters to be determined are: * Plasma PK parameters of Area under the curve (AUC)0-*, AUC0-t, and Cmax of MMF after single dose administration * Plasma PK parameters of AUCext%, tmax, tlag, t*, *z, Cmax/AUC (AI), and mean residence time of MMF after single dose administration. Exploratory analyses of AUC8-24, AUC10-24, and AUC12-24. * Exploratory analyses of whole blood PK parameters of AUC0-*, AUC0-t, and Cmax of the DMF and MMF metabolites after single dose administration * Exploratory analyses of whole blood PK parameters of AUCext%, tmax, tlag, and Cmax/AUC (AI) of the DMF and MMF metabolites after single dose administration * Exploratory analyses of urine PK parameters of Ae(0-t), and Fe(0-t) of DMF and MMF metabolites after single dose administration. Additional exploratory analyses of DMF and MMF metabolites in plasma may be performed at a later stage. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety and tolerability endpoints (Serious) treatment-emergent AEs ((S)TEAEs). Concomitant medication Clinical laboratory tests Haematology Chemistry Urinalysis Vital signs Pulse rate (beats per minute (bpm)) Systolic blood pressure (mmHg) Diastolic blood pressure (mmHg) ECG Heart rate (bpm), PR, QRS, QT, QTc calculated using Fredericia's method (QTcF). | — |
Countries
Netherlands
Outcome results
None listed